Search results for " purity"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Because contaminating cell types can slow or complicate downstream isolation protocols, yield and purity should be balanced with the goal of consistently delivering maximum therapeutic efficacy to the…
Article
Nurturing Knowledge from Disparate Data Streams
For lot release, once a specification (identify, purity, physical form, etc.) has been established and test methods validated for a drug substance, there are many human intervention steps involved to …
Article
Single-Step, Protein A Chromatography Process for Bispecific Antibodies in Early Screening
The goal was to separate BsAb monomer from fragments such as the individual heavy and light chain pairs while achieving high purity and yield of BsAb. MabSelect™ PrismA protein A resin was selected fo…
Poster
Guide to modern BioProcess™ chromatography resins
Based on what protein you would like to purify and the conditions used, chromatography resins are selected to optimize purity and yield. Many bioprocess applications include three chromatography steps…
Article
Process Chromatography Selection for Downstream Processing Applications
…a (MilliporeSigma): It is challenging to compete with a technology able to provide >95% yield and purity with minimal process development required. However, there are mAb purification processes that …
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Viral Clearance Challenges in Bioprocessing
Generally, Greenhalgh notes that virus purity has the biggest impact on the virus filtration step: less purified preparations are more likely to negatively impact the virus filter performance by reduc…
Article
High-Throughput Process Development in an Historical Environment
The challenge was to use HTPD workflows for maximized Dab purity and yield.
A workshop held by Ashley Hesslein from Bayer HealthCare kicked off the meeting. The topic was “Lessons Learned in Build…
Article
Quality by design for biotechnology products—part 1
This is illustrated in Figure 3 for two attributes, purity by IEC and host cell proteins. In the case of purity, the proposed specifications of >95% compared to the clinical experience of >98% would r…
Article
Top Tips for Successful Development of Antibody Chromatography Processes
But working with protein L, that only binds kappa subclass one, three and four, for instance, MabSelect™ VL, you could get a really high purity sample during the capture step. Since the lambda heterod…